CETIRIZINE HYDROCHLORIDE - cetirizine hydrochloride tablet, orally disintegrating 
Aurohealth LLC

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Drug Facts

Active ingredient (in each tablet)

Cetirizine hydrochloride USP 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Tablet melts in mouth. Can be taken with or without water.

adults and children 6 years and over
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over
ask a doctor
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor

Other information

Inactive ingredients

betadex, citric acid anhydrous, colloidal silicon dioxide, crospovidone, dl-alpha-tocopherol, hydroxypropyl cellulose, magnesium stearate, maize maltodextrin, mannitol, microcrystalline cellulose, natural flavourings, sodium bicarbonate, sodium starch glycolate and sucralose.

Questions or comments?
call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST)


Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12 Orally Disintegrating Tablets) Blister Carton

AUROHEALTH

NDC 58602-838-75

*Compare to the active
ingredient of Zyrtec® Allergy

Original Prescription Strength
Cetirizine Hydrochloride
Orally Disintegrating Tablets, USP 10 mg
Antihistamine

Allergy

DISSOLVE TABS

Indoor & Outdoor Allergies

24 Hour
Relief of:        Sneezing
Runny Nose               Itchy, Watery        Itchy Throat
                                         Eyes                   or Nose

Dye-Free

Melts in your mouth
Orange Flavor

Actual Size

12 Orally
Disintegrating
Tablets
10 mg each

figure

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-838
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
BETADEX (UNII: JV039JZZ3A)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSPOVIDONE (35 .MU.M) (UNII: 40UAA97IT9)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize10mm
FlavorORANGEImprint Code CE;10
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58602-838-752 in 1 CARTON09/11/2020
1NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:58602-838-764 in 1 CARTON09/11/2020
2NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:58602-838-1411 in 1 CARTON09/11/2020
3NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:58602-838-1920 in 1 CARTON01/28/2025
4NDC:58602-838-746 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21355709/11/2020
Labeler - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650918514ANALYSIS(58602-838) , MANUFACTURE(58602-838)

Revised: 1/2025
Document Id: ef1f5185-9a05-4092-9bdc-954102616ccb
Set id: 17e93c22-1ff7-4af9-bd5a-448836aec65f
Version: 5
Effective Time: 20250128
 
Aurohealth LLC